Peering within the Innovation Pipeline
We have a plumbing problem in the U.S. Too little of what pours into pipelines flows out at the end.
Typically the pipeline problem refers to our educational system, where millions of children enter into school systems that fail to adequately teach them the math and science skills required to become doctors, scientists and engineers. Lack of enthusiasm for those careers amplifies the problem.
Innovation also faces a similar fate, although from different causes. Plenty of innovative concepts enter the front end, as can be seen by the number of applications filed at the U.S. Patent and Trademark Office. In 2011, patent office took in more than a half million applications for utility patents. But the process between filing a patent, having it approved (if ever) and then getting a product into the marketplace usually is long, arduous and sometimes fruitless.
Our cover story this month addresses cardiovascular innovation. There is an added kink in the pipeline for medical devices and pharmaceuticals. In the U.S., they must receive federal regulatory approval before they can be marketed. The European Union also mandates that devices and drugs pass a regulatory checklist, but the process is less rigorous than in the U.S.
Some argue that puts U.S. innovators at a disadvantage. This is true, but the U.S. also has many advantages. We often boast that the U.S. fosters a more entrepreneurial environment with a more robust venture capital system that funds high-risk, high-reward innovations. Given the barriers identified in our cover story, some devices also fall into the high-risk category, with tantalizing rewards.
But what would be the consequences if most of what entered the pipeline gurgled out? Awash with many new products, would payers, providers and patients be overwhelmed by their choices? Would there be quality issues?
Overly restrictive and tediously slow regulation clogs the pipeline. Nonetheless, some judicious filtering may be a good thing.
Typically the pipeline problem refers to our educational system, where millions of children enter into school systems that fail to adequately teach them the math and science skills required to become doctors, scientists and engineers. Lack of enthusiasm for those careers amplifies the problem.
Innovation also faces a similar fate, although from different causes. Plenty of innovative concepts enter the front end, as can be seen by the number of applications filed at the U.S. Patent and Trademark Office. In 2011, patent office took in more than a half million applications for utility patents. But the process between filing a patent, having it approved (if ever) and then getting a product into the marketplace usually is long, arduous and sometimes fruitless.
Our cover story this month addresses cardiovascular innovation. There is an added kink in the pipeline for medical devices and pharmaceuticals. In the U.S., they must receive federal regulatory approval before they can be marketed. The European Union also mandates that devices and drugs pass a regulatory checklist, but the process is less rigorous than in the U.S.
Some argue that puts U.S. innovators at a disadvantage. This is true, but the U.S. also has many advantages. We often boast that the U.S. fosters a more entrepreneurial environment with a more robust venture capital system that funds high-risk, high-reward innovations. Given the barriers identified in our cover story, some devices also fall into the high-risk category, with tantalizing rewards.
But what would be the consequences if most of what entered the pipeline gurgled out? Awash with many new products, would payers, providers and patients be overwhelmed by their choices? Would there be quality issues?
Overly restrictive and tediously slow regulation clogs the pipeline. Nonetheless, some judicious filtering may be a good thing.